FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
84817–84840 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 08, 1999
QUANTEC-E IRRIGATION SYSTEM 2
K992195 · EIA
Sybron Dental Specialties, Inc.
Dental · 101d
Cleared Oct 08, 1999
MASIMO SET RADICAL PULSE OXIMETER, LNOP-ADT, LNOP-PDT, LNOP-NEO, LNOP-NEO PT,...
K992238 · DQA
Masimo Corp.
Anesthesiology · 98d
Cleared Oct 08, 1999
RX MEGALINK SDS BILIARY STENT SYSTEM, OTW MEGALINK SDS BILIARY STENT SYSTEM
K992319 · FGE
Guidant Corp.
Gastroenterology & Urology · 88d
Cleared Oct 08, 1999
3M CLINPRO SEALANT
K992326 · EBC
3M Company
Dental · 87d
Cleared Oct 08, 1999
EBI OMEGA 21 SYSTEM
K992333 · MNI
Electro-Biology, Inc.
Orthopedic · 87d
Cleared Oct 08, 1999
ENDOSSEOUS IMPLANTS AND ABUTMENTS- TIN COATING
K992334 · DZE
Implant Innovations, Inc.
Dental · 87d
Cleared Oct 08, 1999
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP...
K992340 · DQA
Masimo Corp.
Anesthesiology · 87d
Cleared Oct 08, 1999
CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDS
K992347 · DQO
Cordis Corp.
Cardiovascular · 86d
Cleared Oct 08, 1999
SEALOUETTE FIBRIN SEALANT APPLICATOR
K992351 · FMF
Biosurgical Corp.
General Hospital · 86d
Cleared Oct 08, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK
K992366 · MMI
Ortho-Clinical Diagnostics, Inc.
Chemistry · 85d
Cleared Oct 08, 1999
RC TACK
K992377 · MBI
Innovasive Devices, Inc.
Orthopedic · 85d
Cleared Oct 08, 1999
THE IMPLEX MODULAR ELLIPTICAL POROUS ACETABULAR CUP, MODEL XX-2YY-ZZZZ
K992409 · JDI
Implex Corp.
Orthopedic · 80d
Cleared Oct 08, 1999
PASCO MIC AND MIC/ID PANELS, TROVAFLOXACIN
K992507 · JTN
Pasco Laboratories, Inc.
Microbiology · 73d
Cleared Oct 08, 1999
TECHNOSANAT KRYO TSK 2005
K992536 · GEX
Technosanat Innovative Medizintechnik...
General & Plastic Surgery · 71d
Cleared Oct 08, 1999
AIRIS, AIRIS II
K992650 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 63d
Cleared Oct 08, 1999
MODIFICATION TO BONE MULCH SCREW SYSTEM
K993025 · HWC
Biomet, Inc.
Orthopedic · 29d
Cleared Oct 08, 1999
ACON COMBO PREGNANCY
K993065 · JHI
ACON Laboratories, Inc.
Chemistry · 25d
Cleared Oct 08, 1999
HOWMEDICA OSTEONICS RESTORATION HA HIP STEM
K993077 · MEH
Howmedica Osteonics Corp.
Orthopedic · 24d
Cleared Oct 08, 1999
PURITAN-BENNETT AERIS 590 OXYGEN CONCENTRATOR WITH OCI
K993088 · CAW
Puritan Bennett Corp.
Anesthesiology · 22d
Cleared Oct 08, 1999
HDL-C/LDL-C CALIBRATOR, MODEL 1913-003
K993098 · JIX
Data Medical Associates, Inc.
Chemistry · 22d
Cleared Oct 07, 1999
0.9% SODIUM CHLORIDE FLUSH SYRINGE
K984590 · FOZ
Baxter Healthcare Corp
General Hospital · 283d
Cleared Oct 07, 1999
ANEROID SPHYGMOMANOMETER
K990638 · DXN
Genmed, Inc.
Cardiovascular · 223d
Cleared Oct 07, 1999
CET PROSTATE APPLICATOR SET, PART NUMBER 089.066
K990990 · JAQ
Nucletron Corp.
Radiology · 197d
Cleared Oct 07, 1999
COBE OPTIMIN HOLLOW FIBER MEMBRANE OXYGENATOR
K991452 · DTZ
Cobe Cardiovascular, Inc.
Cardiovascular · 164d